ATI PLASMA PUMP (PP-04)— 510(k) K961137

Name: FDA 510(k) clearance K961137
Creator: U.S. Food and Drug Administration
Published: 1996-06-14

Substantially Equivalent

Apheresis Technologies, Inc.

FDA 510(k) clearance K961137 for ATI PLASMA PUMP (PP-04), Substantially Equivalent on 1996-06-14. Applicant: Apheresis Technologies, Inc.. Device class: 2.

Clearance details

Applicant: Apheresis Technologies, Inc.
Product code: Code FIR
Device class: Class 2
Regulation: 21 CFR 876.5820
Advisory panel: Gastroenterology, Urology
Date received: 1996-03-21
Decision date: 1996-06-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Palm Harbor, FL, US

Download summary PDF View on FDA.gov ↗

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K821139 — SPS-SINGLE PATIENT SYSTEM1982-05-10
K780410 — BLOOD PUMP-MODE S10K1978-05-03
K771705 — RS-7800 MINIPUMP1977-10-04

More clearances from Apheresis Technologies, Inc.

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K926409 — PLASMA DISCARD BAGS1993-03-02

Recalls naming K961137

K-number listed on FDA's recall record

Z-2149-2012 — Plasma Pump Model PP-04a Used with Asahi Plasmaflo Plasma Separators and plasma exchange tubesets to perform therapeutic plasma exchange.Class II·Terminated·Apheresis Technologies, Inc.·20120709

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K961137.

Data sourced from openFDA. This site is unofficial and independent of the FDA.